Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
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| ClinicalTrials.gov Identifier: NCT01933295 |
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Recruitment Status :
Completed
First Posted : September 2, 2013
Last Update Posted : January 31, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Menopause | Behavioral: Cognitive Behavioral Therapy for Insomnia Behavioral: Sleep Education Behavioral: Sleep Restriction Therapy | Not Applicable |
Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.
Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.
Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).
Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes |
| Actual Study Start Date : | March 1, 2014 |
| Actual Primary Completion Date : | December 31, 2018 |
| Actual Study Completion Date : | December 31, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Sleep Education
Weekly educational emails sent to participants with information about sleep science and tips for better sleep.
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Behavioral: Sleep Education |
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Experimental: Cognitive Behavioral Therapy for Insomnia
Behavioral treatment (5 component)
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Behavioral: Cognitive Behavioral Therapy for Insomnia |
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Experimental: Sleep Restriction Therapy
Brief sleep restriction therapy.
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Behavioral: Sleep Restriction Therapy |
- Sleep [ Time Frame: 8 months ]Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up. A total of 4 standarized nocturnal PSGs will be performed for each participant (screening night, baseline assessment, and post-treatment night 1 and post treatment night 2. For each participant, self report sleep diaries will be measured in the home nightly throughout the 2-week baseline, treatment protocols, during the 2 weeks immediately post-treatment and for 2 weeks during follow up assessment at 6 months post treatment.
- Depression [ Time Frame: 8 months ]Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up. Depression will be measured by the administration of the Beck Depression Inventory questionnaire(BDI-II).
- Quality of life [ Time Frame: 8 months ]Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up
- Self-Reported Sleep (Diary) [ Time Frame: 8 months ]
Subjects will be evaluated at pre treatment, post treatment and at approximately 6 months follow up. For each participant, self report sleep diaries will be measured in the home nightly throughout the 2-week baseline, treatment protocols, during the 2 weeks immediately post-treatment and for 2 weeks during follow up assessment at 6 months post treatment.
Home based measures (Diary): Wake after sleep onset; sleep efficiency; total sleep time; sleep latency; number of awakenings
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| Ages Eligible for Study: | 45 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- post-menopausal insomnia
Exclusion Criteria:
- unstable medical conditions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933295
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Principal Investigator: | Christopher Drake, PhD | Henry Ford Health System |
| Responsible Party: | Christopher Drake, Bioscientific Staff, Henry Ford Health System |
| ClinicalTrials.gov Identifier: | NCT01933295 |
| Other Study ID Numbers: |
NR013959 R01NR013959-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 2, 2013 Key Record Dates |
| Last Update Posted: | January 31, 2019 |
| Last Verified: | January 2019 |
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treatment |